cGMP analytical method development and validation for solid form analysis can be a critical component in the drug development process. At SSCI, we take a multidisciplinary approach to the development of quantitative methods. The optimal physical analytical technique (x-ray powder diffraction (XRPD),DSC, TGA, IR, Raman, solid-state NMR, or moisture sorption) is selected and used to develop the analytical methodology. In some cases, only a limit test is needed, whereas in others, a full quantitative method may be needed. In either case, statistical experimental design (DOE) and chemometrics are techniques we frequently use in the method development/validation process. Additionally, all methods are developed and validated in light of the ICH (International Conference on Harmonisation) guidelines (Q2A, Q2B, and Q6A).
SSCI scientists are experts at developing methods to quantify crystalline/crystalline and crystalline/amorphous mixtures in drug product or drug substance.
We can develop a technique with your laboratory capabilities in mind and participate in transfer of a method from our labs to an in-line monitoring system installed on your production line.